Single-use therapeutic substance delivery device with infusion rate control

• US 6,562,000 B2
• Filed: 02/02/2001
• Issued: 05/13/2003
• Est. Priority Date: 02/02/2001
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Mattes, Michael F., Larson, Lary R., Heruth, Kenneth T., Thompson, David L.
• Primary Examiner(s): Derakshani, Philippe
• Application Number:
  US09/776,471
• Publication Number:
  US 20020107472A1
• Time in Patent Office: 830 Days
• Field of Search: 604/509, 604/48, 604/67, 604/132, 606/545
• US Class Current: 604/48
• CPC Class Codes: A61M 2205/3507 with implanted devices, e.g. external control
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 5/152 pressurised by contraction of elastic reservoirs containers for dispensing contents by contraction of an elastic bag provided therein, in general B65D83/0061
• CPC Class Codes: A61M 5/16813 by controlling the degree of opening of the flow line
• CPC Class Codes: A61M 5/16877 Adjusting flow; Devices for setting a flow rate
• CPC Class Codes: A61M 5/16881 Regulating valves on-off valves, e.g. clamps A61M39/28

Abstract

A medical device known as a therapeutic substance delivery device is configured to with an infusion rate control to deliver a therapeutic substance such as pharmaceutical compositions, genetic materials, and biologics to treat a variety of medical conditions such as pain, spastisity, cancer, and other diseases in humans and other animals. The therapeutic substance delivery device can be configured as a single-use device that is versatile, small, inexpensive, and has many other improvements. The single-use device has a Micro Electro Mechanical System (MEMS) flow restriction with a variable infusion rate. The MEMS flow restriction is fluidly coupled to a reservoir outlet to receive therapeutic substance dispensed from the single-use reservoir at the reservoir rate and restrict the therapeutic substance flow to a desired infusion rate. The single-use reservoir is configured for controlled collapse to dispense therapeutic substance from the reservoir at a reservoir rate through a reservoir outlet. The therapeutic substance delivery device can also be configured as a shrink polymer delivery device that is also versatile, small, inexpensive, and has many other improvements. A flow restriction is fluidly coupled to the shrink polymer reservoir outlet to receive therapeutic substance dispensed from the reservoir at the reservoir rate and restrict the therapeutic substance flow to an infusion rate. Many embodiments of the therapeutic substance delivery device with infusion rate control and its methods of operation are possible.

Claims

1. A single-use therapeutic substance delivery device with infusion rate control, comprising:

a single-use reservoir configured for controlled collapsing to dispense therapeutic substance from the reservoir at a reservoir rate through a reservoir outlet; and

,

a Micro Electro Mechanical System (MEMS) flow restriction fluidly coupled to the reservoir outlet to receive therapeutic substance dispensed from the reservoir at the reservoir rate and restrict the therapeutic substance flow to an infusion rate.

2. The single-use therapeutic substance delivery device as in claim 1 wherein the single-use therapeutic substance delivery device is configured to be implanted into a patient.

3. The single-use therapeutic substance delivery device as in claim 2 wherein the single-use therapeutic substance delivery device is configured to be percutaneously inserted into a patient.

4. The single-use therapeutic substance delivery device as in claim 2 wherein the single-use therapeutic substance delivery device is configured to be programmed after implantation.

5. The single-use therapeutic substance delivery device as in claim 1 wherein the single-use reservoir is a shrink polymer reservoir.

6. The single-use therapeutic substance delivery device as in claim 1 wherein the single-use reservoir is an elastomeric bladder.

7. A shrink polymer therapeutic substance delivery device with infusion rate control, comprising:

a shrink polymer reservoir configured for controlled collapsing to dispense therapeutic substance from the reservoir at a reservoir rate through a reservoir outlet; and

,

a flow restriction fluidly coupled to the reservoir outlet to receive therapeutic substance dispensed from the reservoir at the reservoir rate and restrict the therapeutic substance flow to an infusion rate.

8. The shrink polymer therapeutic substance delivery device as in claim 7, further comprising a catheter coupled to the flow restriction, the catheter adapted to be implanted and deliver therapeutic substance to a delivery site at the infusion rate.

9. The shrink polymer therapeutic substance delivery device as in claim 7 wherein the shrink polymer therapeutic substance delivery device is configured to be implanted.

10. The shrink polymer therapeutic substance delivery device as in claim 9 wherein the shrink polymer therapeutic substance delivery device is configured to be percutaneously inserted into a patient.

11. The shrink polymer therapeutic substance delivery device as in claim 9 wherein the shrink polymer therapeutic substance delivery device is configured to be programmed after implantation.

12. The shrink polymer therapeutic substance delivery device as in claim 7, further comprising a safety reservoir to contain therapeutic substance dispensed by the shrink polymer reservoir that has not yet passed through the flow restriction.

13. The shrink polymer therapeutic substance delivery device with as in claim 7, further comprising a capsule containing the shrink polymer reservoir, the capsule being permeable to gas and body fluids, so the gas and body fluids migrate into the capsule as the reservoir collapses to maintain a substantially constant internal pressure within the capsule.

14. The shrink polymer therapeutic substance delivery device as in claim 7 further comprising a check valve coupled to the reservoir outlet.

15. The shrink polymer therapeutic substance delivery device as in claim 7 wherein the flow restriction is a fixed rate flow restriction.

16. The shrink polymer therapeutic substance delivery device as in claim 15 wherein the fixed rate flow restriction is selected from the group consisting of a capillary tube and a precision orifice.

17. The shrink polymer therapeutic substance delivery device as in claim 7 wherein the flow restriction is a variable rate flow restriction.

18. The shrink polymer therapeutic substance delivery device as in claim 17 wherein the variable rate flow restriction is selected from the group consisting of a Micro Electro Mechanical System (MEMS), and a mechanically adjustable flow restriction.

19. A single-use therapeutic substance delivery device with infusion rate control, comprising:

means for containing a therapeutic substance that collapses in a controlled manner to dispense therapeutic substance from the means for containing;

means for restricting flow to restrict therapeutic substance flow from the means for containing to a therapeutic substance infusion rate; and

,

means for delivering therapeutic substance to delivery therapeutic substance at the therapeutic substance infusion rate to a therapeutic substance infusion site.

20. A method for delivering a therapeutic substance from single-use reservoir with infusion rate control, comprising:

containing a therapeutic substance in a single-use reservoir having an reservoir outlet;

collapsing in a controlled manner the single-use reservoir;

raising therapeutic substance pressure contained in the single-use reservoir;

pumping therapeutic substance from the single-use reservoir through the reservoir outlet and into a flow restriction;

controlling therapeutic substance flow from the reservoir outlet with the flow restriction to an infusion rate; and

,

infusing therapeutic substance at the infusion rate.

21. The method as in claim 20, further comprising delivering therapeutic substance through a catheter to a therapeutic substance infusion site.

22. The method as in claim 20, further comprising implanting the single-use reservoir with infusion control into a patient.

23. The method as in claim 20 wherein the single-use reservoir is a shrink polymer reservoir.

24. The method as in claim 20 wherein the single-use reservoir is an elastomeric diaphragm.

25. A Micro Electo Mechanical System (MEMS) variable flow restriction for a single-use therapeutic substance delivery device, comprising:

a substrate having a therapeutic substance flow path with a drug input, a flow restriction, and a therapeutic substance output;

a passive power source carried on the substrate, the passive power source capable of supplying power upon being energized by a radio frequency source;

electronics carried on the substrate and coupled to the passive power supply, the electronics generating a control signal;

.

an actuator carried on the substrate and coupled to the electronics, the actuator moving in response to the control signal; and

,

a valve movably coupled to the substrate to selectively engage the flow restriction, the valve operated by the actuator to selectively adjust the flow restriction to an infusion rate.

26. The MEMS flow restrictor as in claim 25 wherein the electronics include nonvolatile memory.

27. The MEMS flow restrictor as in claim 25 wherein the actuator is a Direct Current (DC) motor coupled to the valve with a gear.

28. The MEMS flow restrictor as in claim 25 wherein the actuator is a heat motor coupled to the valve with a ratchet wheel.

29. The MEMS flow restrictor as in claim 25 wherein the actuator is a stepwise rotor coupled to the valve.

30. The MEMS flow restrictor as in claim 25 wherein the flow restriction is a continuous path.

31. The MEMS flow restrictor as in claim 25 wherein the flow restriction is a plurality of restriction outlets selectable by the valve.

32. The MEMS flow restrictor as in claim 25 further comprising a single-use therapeutic substance reservoir coupled to the MEMS flow restrictor.

33. The MEMS flow restrictor as in claim 32 wherein the single-use therapeutic substance reservoir is a shrink-polymer reservoir.

34. The MEMS flow restrictor as in claim 32 wherein the single-use therapeutic substance reservoir is an elastomeric bladder.

35. A Micro Electo Mechanical System (MEMS) flow restriction for a therapeutic substance delivery device with infusion rate control, comprising:

means for therapeutic substance flow having a therapeutic substance input, a flow restriction, and a therapeutic substance output;

means for power carried on the means for therapeutic substance flow, the means for power capable of supplying power upon being energized by a radio frequency source;

means for programming to store flow restriction program;

means for electronics to receive the flow restriction program and generate a control signal;

means for actuation to create motion in response to the control signal; and

,

means for valuing to adjust therapeutic substance flow through the flow restriction upon operation of the means for actuation.

36. A method for operating a Micro Electro Mechanical System (MEMS) therapeutic substance flow restriction, comprising:

energizing a passive power supply with a radio frequency signal;

powering electronics with the passive power supply;

receiving an information signal modulated on the radio frequency signal with the electronics;

generating a control signal that is responsive to the information signal with the electronics;

operating an actuator in response to the control signal; and

,

adjusting the valve to adjust the flow restriction to an infusion rate.

37. The method as in claim 36, further comprising transmitting a status signal with the electronics.